(92 days)
Alpha Endo Handpiece is a cordless motor handpiece with torque control used for driving files in both reciprocating and rotation mode during the preparation stage of root canal therapy.
The Alpha Endo Handpiece is a medical electrical device that provides the driving force required for surgical instruments used in root canal surgery to enlarge and shape the root canal during root canal surgery. The Alpha Endo Handpiece mainly uses a variable speed gear plate to turn the high speed of the motor into the low speed required for root canal preparation surgery, while obtaining a larger cutting torque, and then further increases or reduces the speed and torque within this range through the speed regulating circuit, making root canal preparation efficient and safe. Speed and maximum torque are selectable and are always controlled by a torque sensor with an automatic protection mode to prevent the file needle from breaking.
N/A
FDA 510(k) Clearance Letter - Alpha Endo Handpiece
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U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.08.00
Silver Spring, MD 20993
www.fda.gov
October 16, 2025
Shenzhen Superline Technology Co., Ltd.
Sara Lai
Quality Manager
Room 302, Nanshan Zhiyuan A4, No.1001 Xueyuan Avenue
Changyuan community, Taoyuan Street, Nanshan District
Shenzhen, Guangdong 518000
CHINA
Re: K252223
Trade/Device Name: Alpha Endo Handpiece (Alpha Endo)
Regulation Number: 21 CFR 872.4200
Regulation Name: Dental Handpiece And Accessories
Regulatory Class: Class I, reserved
Product Code: EKX
Dated: June 25, 2025
Received: September 19, 2025
Dear Sara Lai:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K252223 - Sara Lai Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K252223 - Sara Lai Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
MICHAEL E. ADJODHA -S
Michael E. Adjodha, MChE, RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K252223
Device Name
Alpha Endo Handpiece (Alpha Endo)
Indications for Use (Describe)
Alpha Endo Handpiece is a cordless motor handpiece with torque control used for driving files in both reciprocating and rotation mode during the preparation stage of root canal therapy.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
Prepared on: 2025-07-16
Contact Details
21 CFR 807.92(a)(1)
| Field | Information |
|---|---|
| Applicant Name | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. |
| Applicant Address | Room 302, Nanshan Zhiyuan A4, No.1001 Xueyuan Avenue, Changyuan community, Taoyuan Street, Nanshan District, Shenzhen, 518000 Guangdong, P.R.China Shenzhen Guangdong 518000 China |
| Applicant Contact Telephone | +86(755)2601605 |
| Applicant Contact | Mr. Jinsong Zhou |
| Applicant Contact Email | jszhou@supline.com |
| Correspondent Name | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. |
| Correspondent Address | Room 302, Nanshan Zhiyuan A4, No.1001 Xueyuan Avenue, Changyuan community, Taoyuan Street, Nanshan District, Shenzhen, 518000 Guangdong, P.R.China Guangzhou Guangdong 510000 China |
| Correspondent Contact Telephone | +86 13560193158 |
| Correspondent Contact | Ms. Sara Lai |
| Correspondent Contact Email | Sara.Lai@supline.com |
Device Name
21 CFR 807.92(a)(2)
| Field | Information |
|---|---|
| Device Trade Name | Alpha Endo Handpiece (Alpha Endo) |
| Common Name | Dental handpiece and accessories |
| Classification Name | Handpiece, Direct Drive, Ac-Powered |
| Regulation Number | 872.4200 |
| Product Code(s) | EKX |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K220829 | Endo Motor | EKX |
Device Description Summary
21 CFR 807.92(a)(4)
The Alpha Endo Handpiece is a medical electrical device that provides the driving force required for surgical instruments used in root canal surgery to enlarge and shape the root canal during root canal surgery. The Alpha Endo Handpiece mainly uses a variable speed gear plate to turn the high speed of the motor into the low speed required for root canal preparation surgery, while obtaining a larger cutting torque, and then further increases or reduces the speed and torque within this range through the speed regulating circuit, making root canal preparation efficient and safe. Speed and maximum torque are selectable and are always controlled by a torque
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sensor with an automatic protection mode to prevent the file needle from breaking.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
Alpha Endo Handpiece is a cordless motor handpiece with torque control used for driving files in both reciprocating and rotation mode during the preparation stage of root canal therapy.
Indications for Use Comparison
21 CFR 807.92(a)(5)
Alpha Endo Handpiece is a cordless motor handpiece with torque control used for driving files in both reciprocating and rotation mode during the preparation stage of root canal therapy.
Technological Comparison
21 CFR 807.92(a)(6)
The information in this submission established that the Alpha Endo Handpiece has the same intended use and similar technological characteristics as the predicate device(s). All performance testing met acceptance criteria. Therefore, the Subject Device is substantially equivalent to the predicate device(s).
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.